A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease

Autoimmune Haemolytic Anaemia Clinical Trial

Official title:
A Multicenter, Phase 1b, Open Label, Nonrandomized, Single Dose Study Evaluating the Safety, Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin Disease

Status Completed

Clinical Trial Summary

Primary Objective: To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020 Secondary Objectives: To assess, in participants with cold agglutinin disease, after a single dose of intravenous (IV) BIVV020: - The effect of BIVV020 on complement mediated hemolysis - The pharmacodynamics (PD) of BIVV020 relating to complement inhibition - The pharmacokinetics (PK) of BIVV020 - The immunogenicity of BIVV020

Clinical Trial Description

Up to 23 weeks (screening period up to 8 weeks, treatment period 15 weeks) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04269551
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 1
Start date	June 15, 2020
Completion date	January 6, 2022

View Details

See also
	Status	Clinical Trial	Phase
	Active, not recruiting	`NCT04802057` - Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088	Phase 1
	Completed	`NCT04070612` - National Prospective Cohort for Monitoring Children With Severe Autoimmune Cytopenia.